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临床试验/NCT03684824
NCT03684824Unknown不适用

Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
number of retrieved oocytes

研究概览

简要总结

After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels

详细描述

After detailed history and examination,A transvaginal ultrasound will be done using a transvaginal transducer with 7.5 MHz.

Each ovary will be measured in 3 planes maximal longitudinal, antero-posterior and transverse diameters, D1, D2 and D3 respectively. And ovarian volume will be calculated using the ellipsoid formula:

V = D1× D2 × D3 × 0.523 The volume of both ovaries will be added for the total basal ovarian volume (BOV).

The mean diameter of the antral follicles will be used by measuring the diameter of the follicle in two perpendicular directions.

The total AFC is calculated by counting the follicles with mean diameter 2-10mm in both ovaries.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 20 and 35 age.
  • BMI: 30 -35

排除标准

  • Women less than 19 years or more than 35 years.
  • BMI less than 30 or more than 35
  • Women with Hypothyroidism.
  • Women receiving any treatment may reduce their fertility e.g: chemotherapy.
  • Women with recurrent IVF failure

研究组 & 干预措施

obese group

Other

100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility

干预措施: Long luteal phase GnRH agonist protocol (Drug)

obese group

Other

100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility

干预措施: Gonadotropins (Drug)

结局指标

主要结局

number of retrieved oocytes

时间窗: 34 hours after HCG triggering of ovulation

number of oocytes retrieved at day of ovum pick up

次要结局

  • Clinical pregnancy rate(14 days after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

professor

Cairo University

研究点 (1)

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